PEGASYS PRE-FILLED SYRINGE 135MCG0.5ML

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

PEGINTERFERON ALFA-2A (40KD)

Dostupné z:

DKSH MALAYSIA SDN BHD

INN (Medzinárodný Name):

PEGINTERFERON ALFA-2A (40KD)

Počet v balení:

1Units Units; 4Units Units

Výrobca:

F. HOFFMANN-LA ROCHE LTD

Príbalový leták

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PEGASYS
® PRE-FILLED SYRINGE
Peginterferon alfa-2a (135mcg/0.5ml, 180mcg/0.5ml)
_________________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What PEGASYS is used for
2.
How PEGASYS works
3.
Before you use PEGASYS
4.
How to use PEGASYS
5.
While you are using PEGASYS
6.
Side effects
7.
Storage and disposal of PEGASYS
8.
Product Description
9.
Manufacturer and Product
Registration Holder
1. WHAT PEGASYS IS USED FOR
CHRONIC HEPATITIS B:
In people with a condition where the
liver is scarred but still able to perform
important functions (compensated liver
disease) and evidence of viral growth
and liver inflammation.
CHRONIC HEPATITIS C:
As part of a combination regimen with
other medicines used to treat hepatitis
C
virus
(HCV),
in
people
with
compensated liver disease.
2. HOW PEGASYS WORKS
PEGASYS
belongs
to
a
group
of
medicines
called
interferons.
PEGASYS is a long-acting interferon.
Interferons are proteins that modify the
response of the body's immune system
to
help
fight
infections
and
severe
diseases.
3. BEFORE YOU USE PEGASYS
-
_When you must not take it _
DO NOT USE PEGASYS IF:
1.
You have had an allergic reaction
to alfa interferons, E. coli-derived
products, polyethylene glycol or
any of the ingredients listed at the
end of this leaflet.
Some
symptoms
of
an
allergic
reaction include:
•
hives or skin rash
•
swelling of the face, lips or
tongue
•
wheezing
or
trouble
breathing,
•
faintness
2.
You have a condition where your
immune system attacks your own
liver
and
causes
it
to
become
inflamed.
3.
You have decompensated cirrhosis
(severe liver disease).
4.
You previously have severe pre-
existing heart problems.
5.
You are pregnant.
6.
You are breast-feeding or plan to
breast-feed.
It is not known whether PEGASYS
passes into the breast milk. Your
doctor will discuss the risks and
benefits of using PEGASYS if you
are breast-feeding.
7.
You are also infected with HIV
and
have
chronic
l

Súhrn charakteristických

2211-390
Artwork Request:
131589
Printing Colours:
PANTONE Black C
Comp. Description:
11004157 LEAF 135_180MCG PEGASYS
MY-DIV
Comp. No. New:
11004157_MY_1
Comp. No. Old:
n/a
Format/Dimension:
370 x 1030 mm
Tech. Drawing No.:
NP9359
Pharma Code:
n/a
Min. Font Size Text (RA):
9 pt
Font Type:
OfficinaSansBoldITC Regular;
OfficinaSansBookITC Regular; Times New
Roman Bold, Bold Italic, Italic, Regular
Proof No.:
1
05.12.2022
F. Maier
! PLEASE TURN OVERPRINTING ON !
PEGASYS®
PEGASYS®
PACK INSERT FOR MALAYSIA
PEGASYS®
Peginterferon alfa-2a
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Immunostimulants/Interferons
ATC code: L03A B11
1.2
TYPE OF DOSAGE FORM
Pegasys is supplied as a sterile, ready-to-use liquid for subcutaneous
(SC) injection as pre-filled syringes. The solution is clear and
colourless to light yellow.
•
180 mcg Pegasys Pre-Filled Syringe: each single use syringe contains
0.5 mL with 180 mcg
_ _
peginterferon alfa-2a.
•
135 mcg Pegasys Pre-Filled Syringe: each single use syringe contains
0.5 mL with 135 mcg peginterferon alfa-2a.
1.3
ROUTE OF ADMINISTRATION
Subcutaneous injection
1.4
STERILE / RADIOACTIVE STATEMENT
Not applicable
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient_
: peginterferon alfa-2a.
_Other excipients_
: Sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate,
acetic acid, water for injections.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
CHRONIC HEPATITIS B:
Pegasys is indicated for the treatment of both HBeAg-positive and
HBeAg-negative chronic hepatitis B (CHB) in
non-cirrhotic and cirrhotic patients with compensated liver disease
and evidence of viral replication and liver inflammation.
CHRONIC HEPATITIS C:
Pegasys, as part of a combination regimen with other hepatitis C virus
(HCV) antiviral drugs, is indicated for the
treatment of adults with chronic hepatitis C (CHC) with compensated
liver disease. This includes patients with or without liver cirrhosis,
treatment-naive patients, patients who have failed previous treatment
and pa